Calcinosis Reduction by Pyrophosphate in SSC
The Effect of Orally Administered Pyrophosphate on Calcinosis Formation in Systematic Sclerosis
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
Calcinosis, i.e. crystal-like nodules are troublesome complication of systemic sclerosis, an autoimmune disease. Pyrophosphate inhibits its formation is laborytory. We would like to test if orally administered pyrophosphate prevents calcinosis formation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2023
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2021
CompletedFirst Posted
Study publicly available on registry
July 19, 2021
CompletedStudy Start
First participant enrolled
August 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedMay 25, 2023
May 1, 2023
1.9 years
July 14, 2021
May 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the size of calcinosis nodues.
Volumetric assessment with low energy CT
52 weeks+ 16 weeks
Secondary Outcomes (3)
Change of the severity of sympthoms caused by calcinosis
52 weeks+ 16 weeks
Change of the activity of calcinosis
52 weeks+ 16 weeks
Change of the size of calcinosis by ultrasound
52 weeks+ 16 weeks
Study Arms (2)
Pyrophosphate
EXPERIMENTALDisodium pyrophosphate
Placebo
PLACEBO COMPARATORGlucose
Interventions
Eligibility Criteria
You may qualify if:
- to meet ACR/ EULAR classification criteria
You may not qualify if:
- severe upper minfestation of SSC
- hypo- or hyperthyreoidism
- QT prolongation on ECG
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Szeged Universitylead
- Research Centre for Natural Sciencescollaborator
- University of Debrecen Dept. of Rheumatologycollaborator
Related Publications (2)
Hsu VM, Kozak E, Li Q, Bocskai M, Schlesinger N, Rosenthal A, McClure ST, Kovacs L, Balint L, Szamosi S, Szucs G, Carns M, Aren K, Goldberg I, Varadi A, Varga J. Inorganic pyrophosphate is reduced in patients with systemic sclerosis. Rheumatology (Oxford). 2022 Mar 2;61(3):1158-1165. doi: 10.1093/rheumatology/keab508.
PMID: 34152415BACKGROUNDDedinszki D, Szeri F, Kozak E, Pomozi V, Tokesi N, Mezei TR, Merczel K, Letavernier E, Tang E, Le Saux O, Aranyi T, van de Wetering K, Varadi A. Oral administration of pyrophosphate inhibits connective tissue calcification. EMBO Mol Med. 2017 Nov;9(11):1463-1470. doi: 10.15252/emmm.201707532.
PMID: 28701330BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
László Kovács, MD, Ph.D.
Szeged University
- STUDY DIRECTOR
András Váradi, PhD, DSc
Department of Enzymology, Research Centre for Natural Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 14, 2021
First Posted
July 19, 2021
Study Start
August 1, 2023
Primary Completion
June 30, 2025
Study Completion (Estimated)
June 30, 2026
Last Updated
May 25, 2023
Record last verified: 2023-05